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Ivacaftor Open Label Follow on Study in People with CF who have a Non-G551D CFTR Mutation (112)

Study Type:

Interventional

Intervention Category:

CFTR Modulation

Study Sponsor:

Vertex

Study Phase:

3

Recruitment Status:

Recruiting Completed

Study Drug(s):

Kalydeco

Number of Participants Being Recruited:

90

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

The purpose of this trial is to look at the safety of long - term ivacaftor treatment in people with CF who have a non-G551D CFTR mutation. Participants in this trial must have previously been in the Ivacaftor in People with CF who have the R117H CFTR mutation trial or in the Ivacaftor in People with CF who have a non-G551D gating mutation trial.

ELIGIBILITY

Age:

>= 6 Years

FEV1:

Not Applicable

P. aeruginosa status:

Not applicable

B. cepacia status:

Not applicable

Other Primary Eligibility Requirements:

Participation in either VX-770-110 or VX-770-111. To be eligble for the treatment arm eligible subjects must have completed treatment in either study. To be eligible for the observation arm, subjects must have completed at least 4 weeks of treatment in either VX-770-110 or VX-770-111.

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.